The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
Abbott Molecular Inc.’s recall of certain COVID-19 tests that are at risk of false positive results falls into the class I high-risk category, the US Food and Drug Administration said on 14 October.
The FDA had initially announced the recall of Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP diagnostics on...
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
